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For a long time, patients of many countries have traveled abroad to seek the expertise and advanced technologies and treatments available in medical center. In the recent past, a phenomenon known as medical tourism has emerged. Medical tourism is characterized by the fact that patients choose to bypass care offered in their own communities and travel to other countries in the world to receive a wide variety of medical services. These include cosmetic, cardiac and orthopaedic surgery, stem cell therapies, but also treatments with experimental or registered gene therapy products.

One of the countries that play a major role in medical tourism for gene therapy treatments is China. This is not surprising as China is the first country in the world that has approved commercial gene therapy products which are being hailed as a cure for certain types of cancer (see also section "Gene Therapy in China"). As a result, people from around the world are traveling there in the hope that these new wonder drugs, called Gendicine and Oncorine, will succeed where all else has failed. The number of medical tourism patients is unknown, but estimates are that several hundred patients traveled to China for treatment.

In October 2010, a report was published entitled “International Medical Tourism From the Netherlands for Gene Therapy”. The goal of this study was to identify the scope of patients from the Netherlands who travel abroad for treatment with experimental or registered gene therapy products, and to investigate the nature of the treatments products.

Gendicine and Oncorine China’s first approved gene therapy was Gendicine, produced by Shenzhen SiBiono GeneTech in 2003. It is an adenovirus vector carrying the p53 tumour-suppressor gene. An number of Chinese hospitals offer cancer treatments with Gendicine (see video 1 and 2). The treatment is very expensive, and seems to work also for many other tumor types. In 2005, a second gene therapy product was registered that was developed by Sunway Biotech for treatment of head-and-neck nasopharyngal squamous cell carcinoma. This product, Oncorine (H101), is an oncolytic adenovirus that targets selectively cells that under-express the tumour suppressor protein p53. For more information see section "China and Gene therapy".

Concerns However, these registrations have been questioned by a number of experts and specialist in the field. Patients must be warned that the treatments are experimental at best and that Chinese hospitals are cashing in on desperate patients. The registration of these gene therapeutic medicines to treat head and neck cancer followed a fast track at the Chinese State Food and Drug Administration (SFDA), where safety was considered more important than efficacy. The SFDA is the Chinese counterpart of the US FDA. Approval seems to be given on the basis of tumour shrinkage, rather than extension of patient lifetime. There has been quite some concern from gene therapy researchers elsewhere in the world as to the quality of the trials performed and thereby the safety and efficacy of the treatment (Edelstein, 2007). So far, there has been no official statement from a Society for Gene Therapy on concerns related to gene therapy tourism.

Much attention is also drawn to stem cell-based clinical trials and treatments offered predominantly in China. It should be noted that in contrast to registered gene therapy products, experimental adult stem cells do not require approval from the SFDA. Since the safety and efficiency of stem cell-based clinical trials cannot be guaranteed without the monitoring of the SFDA, concerns have been expressed by experts in the stem cell field as indicated by the article “Stem-cell tourism caution".

In 2008, the International Society for Stem Cell Research issued a press release on their concerns on stem cell tourism. The draft guidelines also urge authorities to “prevent exploitation of vulnerable patients” in countries where practitioners are offering and charging patients for stem cell therapies outside an established clinical trial. The number of patients travelling to China for stem cell treatment has been estimated at 2000 (Regulations Are Needed for Stem Cell Tourism: Insights From China (2010)").

The bottom line is that if you are a patient and thinking to undergo such gene therapy or stem cell therapy treatment, be aware of the possible risks, costs of the treatments and that the effectiveness of the treatments is not fully guaranteed. First consult your doctor about these issues as he or she may be an excellent resource to help identify clinical trials for a particular disease.

Finally, be aware that Gene Therapy Net is not intended to replace or constitute the giving of medical treatments or advice. Gene Therapy Net will not answer any questions related to treatments, medical advice or participation in clinical trials.